Good afternoon, this is the conference operator. Welcome and thank you for joining the Recordati nine-month 2025 Results Conference Call. As a reminder, all participants are in listen-only mode. After the presentation there will be an opportunity to ask questions. If anyone needs assistance during the conference call, they may signal an operator by pressing star and zero on the test. At this time I would like to turn the conference over to Mrs. Eugenia Litz of Recordati Investor Relations. Please go ahead madam.
Thank you and good afternoon everyone. I'm pleased to be here today with Rob Koremans, our CEO, and Luigi La Corte, our CFO, who will present results for the first nine months of 2025. Scott Pescatori, Executive Vice President of Rare Diseases, will provide further insight into the exciting Isturisa opportunity. Also joining for the Q and A session will be Alberto Martinez, Executive Vice President of Specialty and Primary Care, and Milan Zdravkovic, Executive Vice President of R&D. As always, the presentation is available in the investor section of our website. It is now my pleasure to pass the call over to Rob. Please go ahead.
Thank you, Eugenia, and thank you for joining us today. The agenda is a little different from what you've seen in typically quarterly calls. You've all seen the exciting news that we brought out on the peak year sales opportunity with Isturisa, and we wanted to give you a little bit more color on that. Scott's going to do that in just a little while. As these additional investments behind the opportunity of Isturisa will impact the margins in 2026 specifically, we'd like to also give you a little bit more of an update on the outlook, which is also a separate part here in the presentation. Let me just start with the first nine months of this year, and we're delighted that once again we've really got very good results for the first nine months of 2025.
Beginning with the net revenue of EUR 1,960,000,000 and an increase of 12.2% compared to the previous year or 8.1% on a like-for-like and constant exchange rate base with very good momentum across SPC and a step up in growth of rare disease and an adverse impact of the currency of 2% year to date mostly coming from the US dollar and the Turkish lira. EBITDA was EUR 743.9 million, up 11.8% versus prior year with margin at 38% of net revenues. Adjusted net income was EUR 493.1 million, up 10.7% from the previous year and the net income was down by 3.6% from the previous year, reflecting also a one-off provision of EUR 14.1 million which Luigi will talk about a bit further down in the presentation.
As for R&D, I'm very pleased to highlight that in line with plan, enrollment was completed in the Pasireotide phase 2 trial for PBH and we had a very productive meeting with the FDA to define the potential U.S. regulatory pathway for approval of Carxiba in the U.S. Looking ahead, I'm pleased to say that thanks to our strong business momentum we deliver results also this year within the guidance range set at the start of the year, albeit in the lower half of the range due to FX headwinds. They are projected at approximately 3% for the full year and are very likely to persist into 2026. Finally, we are thrilled to update our peak year sales estimates for Isturisa for the fourth time since acquisition.
We're confident to double our peak year sales estimates for Isturisa to greater than EUR 1.2 billion and as we invest actively target the broader non-overt Cushing's syndrome patient population. We're very, very excited about this opportunity and Scott will give you some more insights a bit further down in the presentation. Now let me hand over to Luigi who will take you into more details of our nine months results.
Thank you Rob and good morning. Good afternoon everyone. Delighted and somewhat proud to be able to say for the 24th time actually that we have once again delivered a strong set of quarterly results. I'll give as usual some additional color to the numbers you've seen on the materials. Starting with SPC, I know there's a lot of excitement around the prospects on the rare disease side, but very happy to see that especially primary care has also delivered in the first nine months of the year. A strong performance with and continuing to outperform relevant markets with our promoter portfolio, 5% like-for-like growth at cost and exchange rate, and around half of that rate excluding Turkey. This was achieved in the context of relevant markets which we've seen slightly step down in terms of the rate of growth for a few separate different reasons.
and cold had a soft Q1, recovered a bit in Q2 but was again soft in Q3 and it seems that we're in for a bit of a soft season into 2026. In Turkey we have not seen a price increase yet this year and despite over 30% devaluation in the country it seems authorities are reverting back to potentially only one round of price increases per year versus a cumulative excess of 100% in the previous year. In Italy there's been a general softening of market growth. You remember we said coming into 2025 we felt the stock levels were a little bit high in the market and that softening has allowed us to absorb that and we'll start doing that a little bit more in Q4 and as we get into 2026.
Despite that, very pleased to see all of our core franchises growing nicely driven by a number of products that you see highlighted on the page across both RX and OTC and delighted also with the transition on Baskepa which is starting to contribute obviously but which will ramp up as expected in 2026 and will offset the unfortunate loss of Cardicor, the license for which will not be renewed at a period its expiry in early 2026. It is a local product that we market in Italy with a run rate of around EUR 35 million per year in terms of revenue. You know these, some of these headwinds that I mentioned on SPC together with Cardicor will mean SPC realistically will grow at low single digit in 2026, but we do expect it to return to mid single digit growth in 2027.
As regards to rare disease on slide 5, clearly a very, very strong performance and accelerating in Q3, constant exchange rate growth on a like-for-like basis of 14%, slightly up versus year to date. At the end of year, Scott will talk about Isturisa, so I'll just touch on the other ones, on the other key franchises, and very simply say we continue to be very happy with each of Signifor, Carxiba, and Sylvant growing at double digit and really across geographies, and in Ngimo, despite the summer months being usually slightly softer, posting close to 25% increase on a pro forma basis versus 2024. Very, very strong momentum across all of the key growth franchises combined with a metabolic that continues to be resilient and in fact continuing to show growth, which is net obviously of increasing headwinds on effects on the US dollar.
We do feel really great about the long term growth opportunity in rare disease for what is one of the broadest portfolios in rare disease across the industry. Very briefly on slide 6 on revenue by geography, once again very pleased all regions really are contributing to that momentum. The U.S. is now close to 20% of total revenue and growing in local currency by over 30% and accelerating on the back obviously of the momentum particularly behind the Endo franchise and of course the contribution of Ngimo, which is also contributing to the strong growth in both Germany and the international markets. You'll see very much in line with expectations the more established markets in Europe growing at single digit rates, with on the other hand Russia and other Central Eastern European markets growing strongly at double digit on the back of both volume growth and select price increases.
I like to also call out Turkey, which yes, is being challenged by the high devaluation and the lack of price increases this year, but is continuing to grow double digit and really outperforming the local market in those terms. I am very happy with the revenue performance both looked at from a product lens and geographic one when it comes to the P and L on slide 7. I am very pleased with this double digit growth at the level of both revenue, EBITDA, and adjusted net income, and also very pleased with adjusted gross profit continuing to creep upwards on the back of the changing mix and very solidly above the 70% mark.
Operating expenses are very much in terms of percent of revenue in line with Q2 with a step up versus 2024 reflecting the investments we've started to make behind Isturisa in particular and Ngimo, and which we do expect now to step up. As Rob has mentioned, we did have an unfortunate and unexpected setback in an ongoing litigation that we had with Italian Pharma Agency which took the view that we should have continued to pay a clawback on Uraplex even following the -40% price reduction which we incurred in 2020 when the product lost exclusivity. The company considered that request to be absolutely ungrounded and we still consider it as such. Unfortunately, in the context of budget pressures, the administrative courts ruled against us, as they did also against other pharmaceutical companies in the countries engaged in similar litigation.
That we've taken a provision to cover the cost of that is unfortunate, but really a one off. Notwithstanding that, you know, very strong results, very pleased with the outcome. You recall we said from the start of the year that we expected our Q4 margins to be as usual, lower than the first part of the year, but to be above 2024 levels. With these results, and with that in mind, we're well on track to deliver on the margin objective that we set for 2025. Finally on my side, as you will see from slide 8, we've always on this call also talked about our strong underlying cash flow performance and that remains true.
In this first nine months we took deliberate decision to increase our stock levels and particularly in the U.S. EUR 95 million roughly of that EUR 138 million increase in working capital is due to that which with that increase now covering almost one year worth of shipments into the U.S. we are very pleased with that. Of course with that in order to fund the higher spend on net share buybacks, we now expect leverage at the end of 2025 to be around the current level, just above two times leverage. Once again very happy with the results. With that I will now turn over to Scott to talk about exciting opportunity that we see on Isturisa going forward.
Thank you Rob. Thank you Luigi. This is Scott Pescatori and it's a real pleasure to be here today to provide a bit more color on this exciting opportunity that we have with Isturisa. Before I go there, I'd just like to start off with just a brief update on the current performance of Isturisa on slide 9. We're seeing quite a robust patient uptake in the U.S. since the FDA expanded our label for Cushing's syndrome back in April of this year. As you know, the label has expanded our patient pool quite significantly. The impact is clear from the graph you can see there. Active patients in the U.S. have more than doubled versus previous year to over 1,200 in quarter three, which is quite a nice increase versus quarter two. Importantly, this growth isn't just about new starts, new patient starts.
The patients continue to titrate up to optimal doses, which is also accelerating our revenue. Equally important, the expanded indication is broadening our ability to reach more patients. We are just at the beginning of tapping into this full market potential. There is quite a bit of potential that remains in the Cushing's syndrome market and I will describe that in a bit more detail on slide 10. If we focus on the right-hand part of the slide, the U.S. Cushing's market offers substantial room for growth, especially among what is called so-called non-overt or mild Cushing's syndrome patients. Non-overt mild patients are typically those patients who present with cardiometabolic comorbidities such as persistent and difficult to treat hypertension and/or diabetes, and their cortisol levels tend to be in the range of about 1-2 times upper limit of normal.
These patients are most commonly treated by community endocrinologists, select cardiologists, and primary care physicians. With regards to the dose, we can expect the dose in these patients to be slightly lower than that of overt patients, but that is based primarily on the severity of the disease. If we look at the addressable patient population, there is significant upside opportunity here within this group of patients, potentially exceeding more than 30,000 at peak. By expanding screening, diagnosis, and education, particularly in the community settings, we are well positioned to capture this broader patient base and continue to drive long-term growth of the brand. Move to slide 11. Clearly, you can see that we are raising our ambitions. Our peak year sales target for Isturisa is now more than doubled to greater than EUR 1.2 billion, reflecting our confidence in reaching more non-overt Cushing's patients.
How are we going to achieve this? We're investing approximately EUR 40 million-EUR 50 million annually on things like expanding our US sales, our US field force in the US, our medical science liaisons, generating real world evidence, and conducting a phase 4 randomized controlled trial. Now, just to remember that the study population in this trial is already within our approved indication. The objective of the trial is to give physicians additional data on the use of Isturisa in milder patients. These investments are designed to double our peak year sales by continuing to treat not only the mild patients, but the severe Cushing's disease and severe Cushing's syndrome patients, putting special focus on the non overt segment that's been under diagnosed and undertreated. Ultimately, this will allow us to capture approximately 35% of the addressable population at peak.
The outlook is strong and we're building the infrastructure to capture and sustain this momentum. We're very excited about the road ahead and with that I'd like to turn it back over to Rob.
Thank you, Scott. Looking to the outlook and as mentioned, we anticipate that the robust performance across SPC and rare disease will enable us to achieve our full year targets for 2025 in line with the original guidance. This comes despite a challenging macroeconomic environment and approximately 3% of currency headwinds expected for the full year, and they are likely to persist into 2026. If you look ahead for 2026, we expect sustained high double-digit growth of rare disease at constant exchange rates with revenues nearing 50% of our total revenues. Isturisa will be a key driver, and to fully capture this opportunity, there will be additional investments to target the patients that do not present themselves with all the typical clinical symptoms that you see at Cushing's, but are detected often primarily through persistent hypertension or difficult to treat diabetes.
These so-called non-overt Cushing's syndrome patients are a very significant opportunity and the opportunity to tackle them going forward and help them and support them is what we're really excited about. This underpins our double peak year sales estimates. As a result, 2026 should be an investment year aligned with our updated sales forecast for Isturisa. For SPC we expect low single-digit growth at constant exchange rate, which reflects also the loss of the Cardicor license that Luigi mentioned. The fundamentals of the business remain very strong and intact and we are confident to return to mid single-digit growth in 2027. For 2027 our targets remain unchanged with strong organic growth expected to be complemented by ongoing BD&M and A.
Finally, we are confident in our long term growth prospects supported by the doubling of our peak year estimated sales for Isturisa. Now, together with my colleagues here in the room, I am very happy to turn over to you and take your questions.
Excuse me, this is the call school conference operator. We will now begin the question and answer session. Anyone who wishes to ask a question may press star and one on the third tone telephone. To remove yourself from the question queue, please press star and two. Please pick up the receiver when asking questions. Anyone who has a question may press star and one at this time. The first question is from Shahzad of Jefferies. Please go ahead.
Hi there. Thank you for taking my questions. Two from me please. Happy to take them one at a time. Firstly, given that the midterm guide was reiterated, does that mean the sort of incremental peak sales potential from the non-overt population will likely be realized outside of the midterm period? That's my first question.
Hi Vachaan, maybe I can take that. I think the design was not great. I think the question was as we are confirming 2027 guidance, does that mean the increase in peak is outside of that planning period? No. The short answer is no. Of course, we expect the ramp up already to be steeper on Isturisa. You know, of course as you know, FX has unfortunately moved against us versus when the guidance was set out for 2027. You know, very happy. And do not forget also that 2027 guidance does include the contribution of BD&M and A. You know, we are confident that we can achieve that guidance despite the higher FX. Also on the back of, you know, the increased pace of growth that we expect from the Endo franchise. Does that address your question?
Yeah, that's perfect. Thank you so much. And then just for my second one, sort of looking to 2026 with the OpEx are obviously ramping and rare disease is potentially doing better than current cons expectations and SPC maybe not as strong as where cons is at the moment. How should we be thinking about the margin trends for next year?
Yeah, no, I'm sure many will have the same question, so happy to address that. Look, we're not going to give sort of precise guidance at this point. Right. And that's simply because we typically do that as always, the beginning of next year. We will be reviewing budget in the coming weeks. We have made the decision to invest behind what we feel is a fantastic opportunity and obviously that will weigh on the 2026 margin. I think we've given you some indication of what that kind of looks like. You know, if you take that bottom part of that range of spend around EUR 40 million, that's a point and a half roughly of margin. Of course, the more the mix improves as we go into next year, but we've got effects, you know, going in the opposite direction.
Again, you know, we want to make sure we give you a sense, particularly because of that investment decision that we've taken. We are going to, as always, give more precise targets for next year once we'll have discussed the budget with the board. Is that okay?
Perfect. Thank you so much.
The next question is from Sophia Graf Nielsen of JPMorgan. Please go ahead.
Good afternoon. Thanks for taking my questions. Firstly, just on Isturisa, could you give us any further context on the market research you've done that's given you confidence in expanding the Isturisa opportunity into the non-overt Cushing's syndrome population? Just what are the competitive dynamics in this market and how did you arrive at the assumption of capturing 35% share of the US addressable patient population that underpins your new guide? Also, just in terms of some of the headwinds that you've seen this year, including some of the stocking in Italy, weaker start of the cough and cold season, and pricing dynamics in Turkey.
Can you give us any more color on the magnitude of these impacts and what we should expect for these in Q4 and going into next year?
Maybe I'll start with the second part of the question and apologies, I couldn't catch the name. Sorry, Sophia. So we said in terms of those headwinds, first of all, again, we're very pleased with the momentum to date across both SPC and rare disease. Would expect, as you said, those headwinds to translate into a SPC growth rate for next year in the low single digit rebounding to mid single digit in 2027. When it comes to the more detailed questions around the dynamics on the endo side, I'll pass over to Scott. We'll obviously be conscious it is a competitive field and hence there's a limit to what we will give away in terms of the research that we may have done.
Thanks, Luigi. Hi, Sophia, this is Scott. Thank you for the question. Yes, I mean, to answer your question, in short, we did significant market research around this opportunity. You know, both internal assessment and using external advisors. We spoke to many different endocrinologists and different treaters in the field to verify this market space. There are also other players in this space that are also verifying the patient numbers and this market opportunity with regards to our market share at peak. I mean, this is a competitive market space. It's been competitive and it will continue to increase in its competition. You know, we believe that we can be confident in securing at least a third of those patients and then we'll see how things progress as we, as we move forward.
Thanks a lot.
Next question is from Izako Brambilla of Mediobanca. Please go ahead.
Hi, good afternoon everybody. Thanks for taking my question. I have three that should be quite fast. The first one is on Isturisa. Considering the new sales target and the commentary around different dosage investments behind the product, how should we think regarding the profitability at regime of Isturisa compared to the rest of the rare disease portfolio? Second question is on FX. I know you usually do not give this data, but if you can help us understand the FX headwind on EBITDA this year. So in nine months, 2025, just to have a sort of order of magnitude. Last one is a more strategic one. Considering next year, especially in primary care, will be a year of soft growth. Could you think to restart your M&A campaign in this space doing maybe something more relevant than VASCEPA that you already closed?
Thanks, Izako. I would think VASCEPA is extremely relevant. We indicated for 2027 that we could and will achieve EUR 40 million. That's definitely not the end of the growth for that product. It's an important product for us and for patients and it fits perfectly into our cardiovascular portfolio. I'm really happy with that. I don't think we typically give percentages of profitability and margins on products like Isturisa, but you see that the overall portfolio of rare disease has a slightly higher margin than what we have in SPC. Isturisa is an important contributor of our growth. It's a product that we believe is really well worth investing into. This additional investment, and I think we've stressed that, I believe is fairly, first of all, low risk. We do some clinical work, some medical work, and clearly also commercial.
We do not need a new label for this. We already start seeing patients now with this so-called non overt. We are super excited by it. This is an opportunity that is a bit like launching a new product. It will take time, it will take investments, but that is something that at any time we can always correct and adjust for. Right. That is something that I feel is very, very low investment in terms of the EUR 1.2 billion at least that we can achieve with these revenues. Luigi, you want to take the middle question?
Yeah. On the effects, you're right, Izako, we don't usually give that sort of level detail, but I think it's fair to say it's obviously where we say that we have a 3% headwind on the revenue side. You should expect a lower % at the EBITDA level. You know, let's say around about 2% would probably be the number at the level of EBITDA. As I said, you know, we expect a similar level of headwind when we go into next year also because, as you know, the US dollar devalued after Q1, so we had one, let's say, very positive quarter and then we started to see the devaluation. We'll have most, or expect further devaluation of the dollar next year, but also the full effect of this year's. Does that address your question?
Yes, sure. Many thanks, Martha, for your answer.
The next question is from Charles Maycock of Barclays. Please go ahead.
Hi guys. Charles Speedman King from Barclays. Thanks very much for taking my questions. Just staying on theme here. First question please. Just on Isturisa. Just thinking back to kind of Q1 2025 and discussions around when you previously raised peak sales. This was originally driven by an expanded market outlook. I remember from our conversations that you did not predict further raises to peak sales unless there was going to be a significant market development. I'm just wondering over the past five months, what is it that you define as a significant market development? Is it just your experience of seeing these non-overt patients that you did not expect to see previously?
Or has something changed that makes you more confident that you can in fact change, you know, create this step change in diagnosis and then maybe just if you give us a little bit more of an idea of what that non-overt Cushing's syndrome patient journey looks like just so that we get a bit more of an understanding versus the kind of currently addressed overt Cushing's syndrome patient. I mean, just one quick clarification of could you give us a little bit more detail on what high double digit and approaching 50% means? I mean is this a kind of just entering the range of 17-20% as high teens and is approaching just anything above 45%? Thank you very much.
Thanks, Charles. High double digits in terms of rare disease would be high teens and double digits. It is approaching the 50%. You will see we will be a bit more specific in February, clearly, but we see very good dynamic and that is also answering to your first. The dynamics in the Cushing market, and maybe because there is so much more attention to endocrinology in general, are quite astonishing, and we had frankly not expected to see the ramp up in some of these so-called non-overt patients that do not present themselves with clear Cushing's and clinical symptoms, but you pick up through cardiovascular comorbidity. That is going much better than we expected.
Which prompted us and we had already of course started to do very, very detailed market research like Scott outlined in the U.S. and we actually really see this opportunity. What also helps is we have colleague companies that work, a company like Corcept that works in the same direction, and then the feedback from doctors in the field has just changed over the last couple of months from no, I would never consider to yes, I would absolutely treat. With that, and there is a fairly vast group of patients well beyond the 30,000 that we indicate of people that have high cortisol and also a comorbidity, and we've been maybe even still quite. We are never known to be very aggressive in our assumptions.
We believe that this achievable target audience of something just over 30,000 and to get one third of those patients towards in the coming years, it's like launching a product we believe is highly realistic and we validated this from various parts and now we stand very confident in front of you in that sense.
Right.
It's an exciting opportunity and one it's not what you get every day, an opportunity to almost launch like a new product in value at so low cost and risks. Hence our excitement to share this with you. Does it answer your question?
Yes, it does. Thank you. I mean maybe just focusing a little bit on if you can give us any detail about the kind of difference in the patient journey. I mean are they distinct groups or is it, is it on a sliding scale?
Just let Scott answer that question.
Thank you.
Thanks, Rob. Hi, Charles, it's Scott. Very good question on the patient journey for these. First, on your first question on the market development, we are seeing these patients now. I mean, we do have uptake of these milder patients within the patients that you saw on the slides that we presented. Again, as Rob had mentioned, it really prompted us to do further investigation into this segment and understand what the potential could be and what that looks like over the years and how that's evolving. The patient journey is slightly different for these patients and it's not because typically, as I mentioned in the presentation, they're sitting with really three subgroups of physicians. One is the endocrinologists, two is the cardiologist, and then some of the primary care physicians.
That is based, as Rob had mentioned, on these comorbidities that they present with, which is persistent, kind of difficult to treat hypertension and or diabetes. Patients who have these comorbidities, physicians are now starting to look for reasons why they're not able to treat or control these diseases. They're looking at cortisol levels as a culprit, prompting more cortisol screening for these patients. We're finding that more of these patients are actually showing up with this so-called milder form of Cushing's syndrome with their cortisol levels, as I had mentioned, which is about one to two times upper limit of normal, which is significantly lower than your overt or severe patients.
The point is, is that the journey of these patients, if they're not sitting within the endocrinologist and, you know, keen endocrinologists will identify them and begin treating them, which is what we're seeing now in our numbers. There is a big referral pattern that needs to take place from the cardiologists and the PCPs where these patients could be sitting for them to sort of understand their underlying comorbidities, then test them and then refer them on. The patient journey is slightly longer, which is why we see this opportunity that extends far into the future because the market still needs to develop and get traction.
We do see uptake now and that uptake, as we continue the investment, continue the education, continue all the things that we're investing in the clinical trial, raising awareness, we'll get the traction to get these patients referred on from those other treaters to the endocrinologist and then ultimately treated.
All right, Luigi. Thank you so much.
The next question is from Nicolas Stohler of Kepler. Please go ahead.
Good afternoon, Jens. Thanks for taking my questions. The first one again on high double digit and approaching 50%. Again I was wondering how you can think of keeping together these two things. Because if for you high double digit is 18%, 19%, 17% then special ternary care growth is low single digit, you're not going to get to approach 50%. The other way around, if you're approaching 50%, probably growth in rare disease is going to be higher. Again, if you can clarify a bit on that. Second question on cost associated to Isturisa development. In the press release you talked about EUR 40 million-EUR 50 million and a gradual ramp up to these levels. If I understand well, we should expect EUR 40 million already for 2026. Is this right or not? At least this is what I got from a previous answer.
Last question, just curiosity on Cardicor loss of license. If you can explain what's behind this, which is something quite uncommon. Thank you.
Thanks for your questions. Nicola, let me start with the last one. It's indeed very uncommon. It was the end of a license. The product is returning to its originator and of course we checked whether we have the similar risk in the rest of our portfolio and there is not such risk for the next 10 years. Part of our SBC nature of business is you take licenses and this one, it's. I mean, it's on a full year base EUR 35 million. It's on a EUR 1.5 billion business, of course not the biggest, but it doesn't help in generating growth for next year. That's why we flag it for us. More important is looking at is the similar risk present and the answer is no. Luigi, you want to take some of the questions on the no on the.
Spend for next year. Nicolo, I do not know that we are going to give a lot more than what I said. We said that yes, we started but we have incremental investments which will get to EUR 40 million-EUR 50 million. You should expect the number for next year to be closer to the bottom end of that. As I said, the margin for next year will reflect both that. On the other hand, on the positive, the shift in mix. On the other hand, the adverse effects, and I am not going to give too much more than that at this stage with regards to the growth rates. You should sort of take the, as we said, high teens for the rare disease and approaching is approaching, is not getting to. It is clearly trending in that direction and hopefully that addresses your question, Nicolo.
Yeah, thank you.
The next question is from Martino d'Ambrogio of Equita. Please go ahead.
Thank you. Good afternoon everybody. The first question is on the slide number nine. Would you present the uptake in acceleration for the patients? Could you just very roughly indicate what was the percentage of new active patients coming from the expansion of indication? First question. The second is on the PIC sales guidance. Could you split in your assumption what is the overt and non overt of these PIC sales? Very roughly. When you mentioned 35% in terms of share of patient, is it the same for overt and overt? Could you just very roughly quantify the difference in terms of potential sales of every patient if it's overt or non overt? Very last, sorry, on Isturisa. What is the percentage of sales generated in the US in 2024-2025 as you prefer?
Martino, I understand some of your questions, but you might appreciate that some of this is really competitive and sensitive information which we're not gonna share. We didn't say 45%. If that came across as a percentage market share, it's 35.3-35%. But I mean, we will. We typically don't. I mean, the U.S. is a very important part of our today's sales already. Going forward, it would be actually even more important, right? Because we see the biggest opportunity for this so-called non-overt patients, and that's, that is, it's going to be Isturisa. Isturisa is going to be the major growth driver for Isturisa at the moment. We still have mostly Cushing's disease patients on therapy. With the extension of the label, we got some Cushing's syndromes, and that was, that's the first patients coming in from April this year.
It is still a fairly small percentage. Quite frankly, we were positively surprised by the fact that they did present without us actually really promoting so strongly for this type of patients. It was one of the reasons also to, like Scott said, to really look even deeper into this. At the moment, the vast, vast, vast majority of our patients and revenues with that comes from the more severe or Cushing's disease patients. Some more of the detailed information on what is US Europe, how do we split? I'm sorry, we are not going to disclose simply because that is something that might be too sensitive for the market out there.
Okay, I understand. Thank you.
The next question is from Neil Alexander of Deutsche Bank, please go ahead.
Hi, it's Neil Alexander from Deutsche Bank. Thanks for taking my question. First one on Isturisa and the expansion. Given the investment there, does that impact how you guys will be looking at M&A and business development activity going forward? Obviously, it's going to be a greater focus on Isturisa. Does the strategy there change? That's the first question. The second one on Carxiba and additional data requests from the FDA. Just wondering how that news could potentially impact the peak guidance that you gave earlier this year. Does it mean it might just take a little bit longer to get to that peak sale estimate? Be helpful just to get some color there. Thank you.
Thanks for your questions, Neil. Now if anything, no, our BD&M and A strategy does not change. If anything going forward, Isturisa will help us to fund even better and more deals because it is a really exciting opportunity. Our strategy remains completely unchanged and we will continue to focus both on the SPC side and on rare side and have a couple of really interesting discussions ongoing. On Carxiba, I think you captured it right, but I will ask Milan to give a bit more color on it. It will not change the peak that we guided on. It will take a bit longer to get there. Just for reminder of everyone, we guided EUR 30 million peak year sales for this very restricted and limited group of patients with neuroblastoma and that potential should really still be there if we get the product registered.
I think Milan's actually more optimistic than before, but I'll pass to him to give us some color there.
No, thanks Rob, and thanks for the question. Yes. As we hinted at also in our 2025 call, we were planning to meet with the FDA once we had the first set of data, also to establish, you can say, a potential pathway towards regulatory approval. We have now had the meeting, and it was a very successful meeting. We shared the data from, say, the first data set. FDA wants, you can say, additional data from a second trial, and that trial is already ongoing, and this is what we are guiding towards. As I said, we had a very, you could say, encouraging meeting with the FDA.
Not, you can say, only discussing the data but also starting to elucidate what should a potential BLA package look like. I find that very, very encouraging. I think it's clear that Carxiba addresses an unmet medical need in this relapsed refractory safety segment of neuroblastoma patients. Also I think because of the more benign safety profile, in particular the neurotoxicity in comparison to competition. This unmet need is also recognized by the FDA. I think all in all we are encouraged and we will keep working on potentially getting it approved in the U.S. thanks.
Great, thank you.
The next question is a follow-up of Shahzad of Jefferies. Please go ahead.
Hi there. Thanks for taking my follow-up. Just really quickly, how do you view the sort of current competitive landscape for Cushing, especially given relacorilant's PDUFA at the end of the year? Sort of. How do you think that will change the market dynamic and what will the shape of the market look like?
I don't want to speculate what happens to an FDA approval or not, but frankly, more companies in this field that help to educate patients, doctors to transfer cardiologists to patients with this persistent, difficult to treat hypertension or diabetes or obesity or anything in that field. I think it helps. The education is good in our estimates, like we said, we believe that we would capture one third of this patient population clearly. We are very well aware that Corcept have started to move into this direction long before we did. We believe this can actually really help us. In this case, more companies making sure that these patients are getting diagnosed and transferred and supporting that is a very good and positive thing. We know that our product has a very strong clinical profile both in efficacy and safety. We feel very confident.
This is just also based on today's experience and all the feedback we get from the market that we can capture this market share. We will need to help and develop this market. With that, having more companies in the space is going to be a good thing.
Thank you so much.
Just one other thing to add on top of that, because I completely agree with Rob. We can't forget that. I mean we're talking a lot about these mild or non overt patients. The investment and awareness in Cushing's disease and severe Cushing's syndrome is just as important because there are patients there, there's a market there to be supported, and any awareness or investment in this market will help the broader population of patients as well. This is about building the non overt or the mild population, but it's about supporting and continuing to grow the severe overt population as well. As Rob said, I mean, I think it's important that there's other players in this space and all the investment is welcome to raise awareness and education.
Makes sense. Thank you. The next question is a follow-up of Nicolas Stohler from Kepler. Please go ahead.
Yeah, Stu, please. One on peak sales, should we still think about 2031 as the peak year for Isturisa or should we move, let's say, this a little bit farther in time? Second question. Now you are, with this move, focusing 100% on the U.S., any chance to see a similar move outside the U.S.? Thank you.
Thanks. The focus is on the U.S. because that's where really the big opportunity is. Be assured, we focus on focus, but we push for the rest of the world. Scott's very much a global player and our teams are active in the field of endocrinology everywhere. That is important and I think that's a reality for almost every single rare disease indication in the world. The real big opportunity will be in the U.S., but we are, for instance, also extremely excited about Japan or getting into Brazil. We're doing a really half decent job in Europe as well. It's really a global product and a global effort. Sorry, I forgot your first question. Sorry, Nico.
Was about the PPR sales.
Yeah. Maybe this is one of these products that peaks. Till it does not, it is gonna take a couple of years. It is very difficult. I think by 2031 you will be relatively close to your peak, but there will still be growth. You cannot technically speak. Right. It will take definitely some years because it is a bit like launching a product, really getting a new concept in for patients, for doctors and making sure that these referrals really work. That is something that always takes time. I think we have to be realistic about that. That is how we project it as well.
Yeah. Maybe Nicolo, just to build on that, because if the question behind the question, or if you were mentioning 2031 as being the former planning assumption for loss of exclusivity on Isturisa, I'd just like to remind that already in the three year plan we highlighted that we do see the opportunity and growingly confident around that that this could be extended to 2033 in the U.S. subject to patent term extension. We're also working on a pediatric indication and with the ARB sort of patents in the Orange Book going out to 2035 and you recall in Europe, most major markets, the patent term has already been extended to 2035. I just wanted to make sure that that was clear given that he sort of mentioned 2031.
Thank you. The only thing is that 2033 for the U.S. is still probably a question mark, am I right?
We're really growingly confident. With patents in front of courts, you can never be 100% right. This is really, like Luigi said, pediatric indication. We're progressing really well on that. That's good. The PTE is also looking very, very strong and clear. We're fairly confident on this 33 date.
Thank you.
Next question is from Bruno Permutti of Intesa Sanpaolo. Please go ahead.
Thank you. Good afternoon, everyone. A question again. On Isturisa, the wider population that you are considering now is also a matter of studies, new clinical studies relating to the bar between benefits and cost of treating milder populations also. Milder populations. I want to understand if there are some developments on the market that, in this sense, make you think that it was the right moment to widen the, and to reach also this kind of patient. The second question was relating to the reimbursement. If there will be difference in the reimbursement between milder population treatment or severe population treatment. If you have to change something on that side. The last one was on tariffs. You said that you have a consistent stock in the US on 2026. How do you see the tariff impact? If you can update on this point also.
Thank you.
Let me start with Bruno with the last question. No, we've been building quite significant stock that goes well into 2026, depending on when really and if at all these tariffs come into place. It is a bit speculative at this point in time, but we feel that. For 2026, we've done a lot to be able to mitigate the impact in terms of. I'll pass to Milan and Scott on this question, but I want to really make sure that you understand the current label. We do not need to do the clinical trial to get a label. We have the label. The trial will help to just get more data and evidence for patients to be able to get treated and doctors to feel comfortable about it. The current label actually really covers these patients.
We already, like we said, see patients that get treated with this today. It's also not something that depends on the reimbursement, but maybe. Scott, Milan, you want to extend a little bit on it?
Yeah, sure. Thanks, Rob. Just very quickly, on the reimbursement side, we do not anticipate any additional hurdles in respect to what we do today. First, because this is already within our label, within Cushing's syndrome. These patients are diagnosed with Cushing's syndrome and they are seen by the endocrinologists. All the three sort of areas that we are seeing in severe patients today. The reimbursement process will remain largely the same for over just expanding the population. With regards to coming back to your question on, we discussed it a bit earlier on how we arrived at this opportunity. As Rob had mentioned, we are seeing these patients today and it prompted us to do additional investigation on the market viability of looking at patients that have a slightly lower cortisol level with comorbidities, as I mentioned, in hypertension and diabetes.
are also other players in the market now that have generated some robust phase 3 data with patients suffering from comorbidity and having lower levels of cortisol. Those are some of the data points that we use in addition to the research that we have done and discussions that we have had with a pretty large base of endocrinologists around the opportunity here. Maybe, Milan, you have some additional.
No.
Okay, Bruno, let me know if that further clarifies.
Thank you. Thank you.
Management. There are no more questions registered at this time.
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